FDAHealthJune 20, 2025

Baxter Healthcare Corporation — Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2

⚠️ Certain Spectrum infusion pumps may have an incorrect version of software.

Is this relevant to me?

Geography: US, CA, FL, IL, KS, MI, MS, NY, OH, OK, VA
Source agency: FDA
Category: Health
Published: June 20, 2025

US States: CA, FL, IL, KS, MI, MS, NY, OH, OK, and VA.

What's affected?

Product: Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Brand: Baxter Healthcare Corporation
Lot code: UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201

Additional details

UDI-DI: 00085412498683; Serial Numbers: 2006307 , 2052091 , 2093765 , 2095360 , 2104302 , 2119236 , 2141815 , 2025925 , 2067699 , 2094483 , 2095541 , 2105238 , 2119436 , 2143406 , 2034297 , 2074097 , 2094580 , 2096351 , 2105769 , 2135482 , 2143684 , 2051591 , 2090658 , 2095202 , 2096856 , 2118940 , 2137976 , 2156201

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 28 units.

View original FDA notice →

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